A nasal respiratory device as described herein may be used to treat a subject with a respiratory disorder, including, but not limited to, sleeping disorders such as apnea (including OSA), COPD, snoring, and the like.
Obstructive sleep apnea (OSA) is a disruption of a subject's breathing during sleep. If left untreated, sleep apnea can be life-threatening. Further, OSA may lead to sleep deprivation and a resultant decrease in alertness. Thus, OSA may pose a significant public health issue, as it has a higher prevalence among those engaged in the trucking and transportation industries as compared to the general population.
Currently, the most widely recommended treatment for sleep apnea is continuous positive airway pressure (CPAP). CPAP involves the active application of pressurized airflow, and requires that the patient wear a mask-like device while sleeping; the mask directs the positive airflow into the patient's airway in order to prevent the airway from collapsing. Despite the positive aspects of CPAP treatment, patient compliance has proven difficult to achieve. CPAP can cause nasal congestion, claustrophobic sensations, and other side effects. Patients frequently complain of the discomfort of wearing the mask while sleeping, as well as the noise and constriction of the air supply. Adequate compliance is being recognized increasingly as a major determinant of treatment success, and various strategies have been employed to enhance compliance with CPAP. Compliance is further confounded because patients may remove the CPAP mask as they are falling asleep or after sleeping with the mask for a short period of time. Most CPAP devices now contain circuitry that records hours of usage and the pressure at any given time. Software tools may be used to help the respiratory therapist monitor how patients are using CPAP.
Recently, passive nasal respiratory devices have been developed which may be used in place of (or in conjunction with) active nasal respiratory devices such as CPAP. For simplicity, these passive nasal respiratory devices are referred to herein as simply “nasal respiratory device” or “nasal devices”. In general, these nasal respiratory devices are configured to inhibit exhalation more than inhalation in a sleeping patient. The resistance to exhalation may be considered “passive,” since it is applied by a passive airflow resistor, rather than relying on the active application of force (e.g., air). The nasal respiratory devices may be configured to provide resistance to either or both exhalation and inhalation within a specified therapeutic range or ranges for the treatment of apnea, snoring, or other disorders. As used herein, a patient may be any subject, human or non-human, in need of the nasal respiratory (“nasal”) devices described herein or in the incorporated references. These devices may be provided as prescription or non-prescription (“over the counter”) devices.
Such nasal respiratory devices have been well-described in the following patents and patent applications, each of which is herein incorporated by reference in its entirety: U.S. patent application Ser. No. 11/805,496, titled “NASAL RESPIRATORY DEVICES,” filed on May 22, 2007, now U.S. Pat. No. 7,856,979; U.S. patent application Ser. No. 11/759,916, titled “LAYERED NASAL DEVICES,” filed on Jun. 7, 2007, now U.S. Publication No. 2007/0283962; U.S. patent application Ser. No. 11/298,339, titled “RESPIRATORY DEVICES,” filed on Dec. 8, 2005, now U.S. Pat. No. 7,798,148; U.S. patent application Ser. No. 11/298,362, titled “METHODS OF TREATING RESPIRATORY DISORDERS,” filed on Dec. 8, 2005, now U.S. Pat. No. 7,735,491; U.S. patent application Ser. No. 11/298,640, titled “NASAL RESPIRATORY DEVICES,” filed on Dec. 8, 2005, now U.S. Pat. No. 7,735,492; U.S. patent application Ser. No. 12/141,875, titled “ADHESIVE NASAL RESPIRATORY DEVICES,” filed on Jun. 18, 2008, now U.S. Publication No. 2007/0050144; U.S. patent application Ser. No. 11/811,401, titled “NASAL RESPIRATORY DEVICES FOR POSITIVE END-EXPIRATORY PRESSURE,” filed on Jun. 7, 2007, now U.S. Pat. No. 7,806,120; U.S. patent application Ser. No. 11/941,915, titled “ADJUSTABLE NASAL DEVICES,” filed on Nov. 16, 2007, now U.S. Publication No. 2008/0178874; U.S. patent application Ser. No. 11/941,913, titled “NASAL DEVICE APPLICATORS,” filed on Nov. 16, 2007, now U.S. Publication No. 2008/0142018; U.S. patent application Ser. No. 11/811,339, titled “NASAL DEVICES,” filed on Jun. 7, 2007, now U.S. Pat. No. 7,506,649; U.S. patent application Ser. No. 12/044,868, titled “RESPIRATORY SENSOR ADAPTERS FOR NASAL DEVICES,” filed on Mar. 7, 2008, now U.S. Pat. No. 7,506,649; U.S. patent application Ser. No. 12/369,681, titled “NASAL DEVICES,” filed an Feb. 11, 2009, now U.S. Publication No. 2009/0188493; U.S. patent application Ser. No. 12/364,264 titled “CPAP INTERFACE AND BACKUP DEVICES,” filed on Feb. 2, 2009, now U.S. Publication No. 2009/0194109; U.S. patent application Ser. No. 12/329,271, titled “PACKAGING AND DISPENSING NASAL DEVICES,” filed on Dec. 5, 2008, now U.S. Publication No. 2009/0145788; U.S. patent application Ser. No. 12/329,895 titled “DELAYED RESISTANCE NASAL DEVICES AND METHODS OF USE,” filed on Dec. 8, 2008, now U.S. Publication No. 2009/0145441; U.S. patent application Ser. No. 12/405,837, titled “NASAL DEVICES WITH NOISE-REDUCTION AND METHODS OF USE,” filed on Mar. 17, 2009, now U.S. Publication No. 2009/0241965; U.S. patent application Ser. No. 12/485,750, titled “ADJUSTABLE RESISTANCE NASAL DEVICES,” filed on Jun. 16, 2009, now U.S. Publication No. 2009/0308398; and PCT Patent Application Serial No. PCT/US2009/056948, titled “NASAL DEVICES, SYSTEMS AND METHODS,” filed on Sep. 15, 2009, now International Publication No. WO 2010/031040.
In general, these nasal respiratory devices are configured to inhibit exhalation more than inhalation in a sleeping patient. The resistance to exhalation may be considered “passive,” since it is applied by a passive airflow resistor, rather than relying on the active application of force e.g., air). The nasal respiratory devices may be configured to provide resistance to either or both exhalation and inhalation within a specified therapeutic range or ranges for the treatment of apnea, snoring, or other disorders. As used herein, a patient may be any subject, human or non-human, in need of the nasal respiratory (“nasal”) devices described herein or in the incorporated references. These devices may be provided as prescription or non-prescription (“over the counter”) devices.
These patents and patent applications generally describe nasal respiratory devices and methods for treating a variety of medical conditions through the use of such devices, and are not limited to apnea (e.g., obstructive, central, complex and mixed apnea). These medical conditions include but are not limited to snoring, Cheyne Stokes breathing, UARS, COPD, hypertension, asthma, GERD, heart failure, and other respiratory and sleep conditions. Such nasal respiratory devices typically induce positive end-expiratory pressure (“PEEP”) and/or expiratory positive airway pressure “EPAP”), and are adapted to be removably secured in communication with a nasal cavity. Similarly, the respiratory devices described herein may include devices having one or more expiratory resistor valves.
These devices may include an opening (which may form a passageway), an airflow resistor (e.g., valve) in communication with the opening, and a holdfast to secure the device in communication with a nostril, nasal opening and/or nasal passage. For example, the holdfast may be configured to removably secure the respiratory device within (or over or around) the nasal cavity. The airflow resistor (which may be a valve) is typically configured to provide greater resistance during exhalation than during inhalation.
Although general descriptions of these devices have been described both functionally and by example, certain variations of nasal respiratory devices have not previously been described. Thus, it may be beneficial to improve upon the devices, kits and methods previously described, and particularly to more fully develop certain embodiments of nasal devices and methods of arranging, using, manufacturing, inserting and removing nasal respiratory devices. Described below are specific variations of nasal devices, methods of using nasal devices and kits including such nasal devices.
For example, it would be beneficial to provide nasal devices that are adapted for ease of use, including application. It would also be beneficial to provide nasal devices that more readily form a seal. It would also be beneficial to provide nasal devices that are quiet, or minimize the noise of operation when the subject is breathing through the device, particularly in a low-profile layered) nasal device, such as those described herein. Finally, it would be beneficial to provide nasal devices that may be economically fabricated or manufactured, including nasal devices that are fabricated from a limited number of parts or layers. It would also beneficial to provide nasal devices that may be fabricated inexpensively with high tolerance and reproducibility.
The nasal devices, kits, systems and methods described herein address many of the potential benefits described above. In particular, the nasal devices described herein are passive nasal devices having a low profile that may be fabricated economically, and may have reduced operation noise, while still inhibiting exhalation more than inhalation with a therapeutically relevant range of resistances.
Further, the nasal devices described herein are typically more comfortable, less expensive, and easier to use than the CPAP and other active respiratory devices (e.g., devices or systems that actively apply air or airflow). It may also be desirable to monitoring compliance for patient treatment with these devices. Thus, it may be beneficial to provide devices, systems and methods for monitoring usage/compliance of any of these passive respiratory devices. Described herein are devices, systems and methods that may address this need and allow monitoring of compliance and/or use of the passive nasal devices described.